TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	23	23
Insufficient Information	5	5
Device Dislodged or Dislocated	4	4
Appropriate Term/Code Not Available	3	3
Inadequacy of Device Shape and/or Size	3	3
Malposition of Device	2	2
Device Appears to Trigger Rejection	2	2
Output Problem	2	2
Expulsion	2	2
Material Protrusion/Extrusion	1	1
Mechanical Jam	1	1
No Apparent Adverse Event	1	1
Patient Device Interaction Problem	1	1
Difficult to Remove	1	1
Material Erosion	1	1
Migration or Expulsion of Device	1	1
Unsealed Device Packaging	1	1
Patient-Device Incompatibility	1	1
Improper or Incorrect Procedure or Method	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	16	16
Pain	7	7
Bacterial Infection	6	6
Impaired Healing	4	4
Insufficient Information	4	4
Swelling/ Edema	3	3
No Clinical Signs, Symptoms or Conditions	3	3
Fluid Discharge	3	3
No Code Available	3	3
Cerebral Edema	2	2
Device Embedded In Tissue or Plaque	2	2
No Information	2	2
Failure of Implant	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Meningitis	2	2
Post Operative Wound Infection	2	2
Pocket Erosion	2	2
Inflammation	2	2
Wound Dehiscence	1	1
Airway Obstruction	1	1
Purulent Discharge	1	1
Ecchymosis	1	1
Edema	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
Loss of Range of Motion	1	1
Skin Erosion	1	1
Swelling	1	1
Discomfort	1	1
Deformity/ Disfigurement	1	1
Inadequate Osseointegration	1	1
Foreign Body In Patient	1	1
No Known Impact Or Consequence To Patient	1	1
Skin Infection	1	1
Physical Asymmetry	1	1